- Are you looking for a meaningful new opportunity to test and growth your quality systems skills? We have an immediate need for a Specialist QA to join AML's Inspection and Packaging - Quality Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
The Specialist QA role will bring forth out of the box thinking, an agile mindset and proven subject matter expertise and innate understanding of Quality processes and controls in support of Inspection and Packaging manufacturing plant - AML1 in New Product Introduction initiatives and Projects. The AML-1 Facility is a multi-product Drug Product Inspection and Packaging Manufacturing Operations.
A Day In The Life...
Through an outstanding Quality oversight on-the-floor, you will be responsible to ensure operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed accordingly cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products.
Specific responsibilities include but are not limited to:
- You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, including but not limited to Deviation's, CAPAs, and validations
- Actively engage in Continues Improvement initiatives, programs and projects
- Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures
- Certify that deviations from established procedures are investigated and documented per procedures
- Ensures that production records and testing results are complete, accurate, and detailed according to written procedures and cGMP requirements
- To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
- Strategic advisor to senior management of quality, compliance, supply and safety risks
- Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
- Accountable for assigned training adherence to permit execution of required tasks
Work will also include:
- Champion Continuous Improvement initiatives and projects
- Provides support and oversight of New Product Introduction (NPI)
Basic Education & Experience
Master's degree and 3 years of Quality or Manufacturing experience in GMP regulated environment
Bachelor's degree and 5 years of Quality or Manufacturing experience in GMP regulated environment
Beyond that, the preferred qualifications are:
- Educational background in Life Science or Engineering
- Validated expertise in Quality Systems such as Non Conformance, CAPA, and Change Control
- Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
- Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
- Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
- Validated experience in Commissioning and Qualification
- Strong organizational skills, including ability to follow assignments through to completion
- Enhanced skills in leading, influencing and negotiating
- Demonstrate ability to interact with regulatory agencies
- Solid word processing, presentation, database and spreadsheet application skills
- Strong communication (both written and oral), facilitation and presentation skills
- Proven skill in working independently and to effectively interact with all levels throughout the organization
- Advanced data trending and evaluation
- Ability to evaluate compliance issues
Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us passionate about your well-being too.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.